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The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282594
First Posted: January 27, 2006
Last Update Posted: January 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by:
Genesys
  Purpose
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Condition Intervention
Sepsis Respiratory Failure Renal Failure Surgical Site Infection Drug: Novolin R (human recombinant Insulin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.

Resource links provided by NLM:


Further study details as provided by Genesys:

Primary Outcome Measures:
  • Mortality

Secondary Outcome Measures:
  • Length of ICU Stay
  • Ventilatory Requirement
  • Vasopressor Support
  • Incidence of Renal Failure
  • Incidence of Wound Infection

Estimated Enrollment: 317
Study Start Date: July 2003
Estimated Study Completion Date: October 2005
Detailed Description:
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability

Exclusion Criteria:

  • Under age 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282594


Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys
Novo Nordisk A/S
Investigators
Principal Investigator: Michael Kia, DO Genesys Regional Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00282594     History of Changes
Other Study ID Numbers: GRMC 050023
First Submitted: January 26, 2006
First Posted: January 27, 2006
Last Update Posted: January 27, 2006
Last Verified: November 2005

Keywords provided by Genesys:
Intensive Insulin Therapy
General Surgical
Vascular Surgical
Tight Glycemic Control

Additional relevant MeSH terms:
Renal Insufficiency
Respiratory Insufficiency
Surgical Wound Infection
Kidney Diseases
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs


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